5 results
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15ms
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Sources: EU EUDAMED, US FDA
MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
FDA Enforcement
Class II
·Terminated·Mevion Medical Systems, Inc.·July 29, 2020
MEVION S250i, MEVION S250; Proton Radiation Treatment System
FDA Enforcement
Class II
·Terminated·Mevion Medical Systems, Inc.·July 1, 2020
MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation
FDA Enforcement
Class II
·Terminated·Mevion Medical Systems, Inc.·December 2, 2020
Azurion 5 M12; System Code: (1)722227, (2)722231;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Artis zee biplane, Model Number 10094141
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022